In many instances, it is desired to have a pre-separator for aerosols that are being passed through a cascade impactor for classification, where the larger particles will be removed before entering the impactor.
A cascade impactor utilizing a pre-separator is shown in U.S. patent application Ser. No. 09/679,963, filed Oct. 5, 2000. The type of impactor that may utilize a pre-separator is one which has very low volume of active material that is to be analyzed, with the active material incorporated in a flow of fluid that includes inert particles that are relatively large. The larger inert particles do not enter into the analysis, but are needed for carrying the active materials in a dispersed fashion throughout the charge of gas.
A pre-separator is frequently required when measuring the aerodynamic size of particles discharged from dry powder inhalers because these formulations often contain a significant portion of diluent or carrier particles. The diluent, usually lactose, consists predominantly of particles larger than 20 micrometers, whereas the fine particles containing drug are substantially smaller than 10 micrometers. The large material causes problems for the characterization of aerodynamic size via cascade impaction because the amount is so large that it overloads the holding capacity of the first stage of the impactor. Consequently, large particles can bounce through to finer stages in the impactor, skewing the size distribution. Furthermore, when the diluent particles are very much larger than the cut point of the first stage, they may not be captured efficiently even at low loading levels.
The present invention relates to a pre-separator for use with a cascade impactor that will separate large particles that are well outside of the range of interest in the impactor from the flow. The pre-separator utilizes a two stage separator arrangement, including one stage in which a low viscosity liquid is held in a cup, and against which the direct fluid input is impacted, and a second stage separator that provides for a flow through orifices or openings arranged annularly around the center cup. The two stage impaction in the pre-separator provides the ability to operate at a much wider flow rate range than with prior single stage pre-separators. A flow in the range of 30 to 100 liters per minute can be handled. This wide range of flows permits use of a single pre-separator for several impactor designs.
The inlet fitting to this pre-separator can be a standard USP inlet. The outlet of the pre-separator can slip into an inlet fitting for the impactor unit.